TriangleNCT00364013 · OUTCOME
Duration of Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.
What was measured
Duration of response was calculated only for those participants with a confirmed CR or PR, as the time from the first CR or PR (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified RECIST criteria, based on a blinded central review.
Analysis population: KRAS Evaluable Central Tumor Response Analysis Set: Responders
Groups in this outcome
Wild-type KRAS - FOLFOX + Panitumumab
Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
Wild-type KRAS - FOLFOX
Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
Mutant KRAS - FOLFOX + Panitumumab
Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
Mutant KRAS - FOLFOX
Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
| Group | Source count |
|---|---|
| Wild-type KRAS - FOLFOX + Panitumumab | 175 |
| Wild-type KRAS - FOLFOX | 154 |
| Mutant KRAS - FOLFOX + Panitumumab | 85 |
| Mutant KRAS - FOLFOX | 85 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Wild-type KRAS - FOLFOX + Panitumumab | 11.1 | Not reported | 9.5 | 13.0 | Not reported |
| Wild-type KRAS - FOLFOX | 8.8 | Not reported | 7.8 | 9.7 | Not reported |
| Mutant KRAS - FOLFOX + Panitumumab | 7.4 | Not reported | 5.9 | 8.3 | Not reported |
| Mutant KRAS - FOLFOX | 8.0 | Not reported | 6.5 | 9.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.5
- upper Limit
- 13.0
- value
- 11.1
- group Id
- OG001
- lower Limit
- 7.8
- upper Limit
- 9.7
- value
- 8.8
- group Id
- OG002
- lower Limit
- 5.9
- upper Limit
- 8.3
- value
- 7.4
- group Id
- OG003
- lower Limit
- 6.5
- upper Limit
- 9.5
- value
- 8.0
- denoms
- counts
- group Id
- OG000
- value
- 175
- group Id
- OG001
- value
- 154
- group Id
- OG002
- value
- 85
- group Id
- OG003
- value
- 85
- units
- Participants
- description
- Duration of response was calculated only for those participants with a confirmed CR or PR, as the time from the first CR or PR (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified RECIST criteria, based on a blinded central review.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Wild-type KRAS - FOLFOX + Panitumumab
- description
- Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
- id
- OG001
- title
- Wild-type KRAS - FOLFOX
- description
- Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
- id
- OG002
- title
- Mutant KRAS - FOLFOX + Panitumumab
- description
- Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
- id
- OG003
- title
- Mutant KRAS - FOLFOX
- param Type
- MEDIAN
- population Description
- KRAS Evaluable Central Tumor Response Analysis Set: Responders
- reporting Status
- POSTED
- time Frame
- Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice